A Randomized, Double Masked, Parallel Group, Dose-finding Study to Evaluate SYL1801 in Patients With Neovascular Age-related Macular Degeneration (AMD)

• Sponsor: Sylentis, S.A. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05637255
• Collaborator: (none)
• Enrollment: 90
• Locations: 16
• Arms: 3
• Anticipated Duration (Months): 12
• Patients Per Site: 5.6
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

The goal of this clinical trial is to compare the safety and effect on visual acuity of three different doses of SYL1801 eye drops.

Condition or Disease	Intervention/Treatment	Phase
Wet Macular Degeneration; Neovascular Age-related Macular Degeneration; Macular Degeneration	Drug: SYL1801	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double Masked, Parallel Group, Dose-finding Study to Evaluate SYL1801 in Patients With Neovascular AMD
• Actual Study Start Date: Nov 22, 2022
• Anticipated Primary Completion Date: Jul 22, 2023
• Anticipated Study Completion Date: Nov 22, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SYL1801 ophthalmic solution Low Dose once daily 42 treatment days	Drug: SYL1801; 1 drop in the eligible eye
Experimental: SYL1801 ophthalmic solution Middle Dose once daily 42 treatment days	Drug: SYL1801; 1 drop in the eligible eye
Experimental: SYL1801 ophthalmic solution High Dose once daily 42 treatment days	Drug: SYL1801; 1 drop in the eligible eye

Outcome Measures

Primary Outcome Measures

1. Change from Baseline on visual acuity on Day 42 after last instillation of the assigned dose level [42 days after first administration]

   ETDRS chart

Secondary Outcome Measures

1. Proportion of subjects within each cohort who maintained visual acuity on Day 42 after last instillation of the assigned dose level [42 days after first administration]

   ETDRS chart

2. Proportion of subjects within each cohort who gained visual acuity on Day 42 after last instillation of the assigned dose level [Through study completion, up to 42 days]

   ETDRS chart

3. Proportion of subjects within each cohort who needed rescue medication at any point of the study [Through study completion, up to 42 days]

4. Change from Baseline on flow area on Day 42 after last instillation of the assigned [42 days after first administration]

   Optical Coherence Tomography Angiography (OCTA)

5. Change from Screening on leakage area on Day 42 after last instillation of the assigned [43 days after first administration]

   Fluorescein Angiography

6. Change from Baseline on intraocular pressure (IOP) [42 days after first administration]

   Tonometry

7. Adverse Event Evaluation [Through study completion, up to 42 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Signed informed consent

• Active subfoveal or juxtafoveal choroidal neovascularization secondary to AMD

• Best Corrected Visual Acuity (BCVA) between 70-25 letters (ETDRS) at Screening

• Intraretinal or subretinal fluid

• Central Subfield Thickness > 300 µm

Exclusion Criteria:

• Pregnant or breastfeeding females or those with a positive pregnancy test.

• Females of childbearing potential who will not use a medically acceptable contraceptive method

• Current, previous chronic or recurrent condition according to the investigator's judgement.

• Concomitant treatment or prior ocular procedure or surgery, or alteration of the dose of systemic medications

• Concurrent disease in the study eye

• Previous treatment with systemic anti-Vascular Endothelial Growing Factor (Anti-VEGF) drugs or pro-VEGF treatments

• Concurrent disease in the study eye, other than AMD

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	SYL1801 Investigative Site	Brno		Czechia	62500
2	SYL1801 Investigative Site	Chomutov		Czechia	43001
3	SYL1801 Investigative Site	Frýdek-Místek		Czechia	738 01
4	SYL1801 Investigative Site	Kyjov		Czechia	69701
5	SYL1801 Investigative Site	Liberec		Czechia	46063
6	SYL1801 Investigative Site	Ostrava		Czechia	70200
7	SYL1801 Investigative Site	Praha		Czechia	14000
8	SYL1801 Investigative Site	Praha		Czechia	17000
9	SYL1801 Investigative Site	Gdansk		Poland	80-809
10	SYL1801 Investigative Site	Kraków		Poland	31-070
11	SYL1801 Investigative Site	Rzeszów		Poland	35-017
12	SYL1801 Investigative Site	Warsaw		Poland	01-258
13	SYL1801 Investigative Site	Bratislava		Slovakia	85107
14	SYL1801 Investigative Site	Košice		Slovakia	04011
15	SYL1801 Investigative Site	Poprad		Slovakia	05801
16	SYL1801 Investigative Site	Žilina		Slovakia

Sponsors and Collaborators

• Sylentis, S.A.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sylentis, S.A.
• ClinicalTrials.gov Identifier: NCT05637255
• Other Study ID Numbers: SYL1801_II; 2022-000214-34
• First Posted: Dec 5, 2022
• Last Update Posted: Jan 26, 2023
• Last Verified: Jan 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Sylentis, S.A.: siRNA; oligonucleotide
• Additional relevant MeSH terms: Macular Degeneration; Wet Macular Degeneration

Study Results

No Results Posted as of Jan 26, 2023